OBJECTIVE: To compare three intensive management strategies with respect to metabolic control (glycated haemoglobin, preprandial blood glucose, lipid profile, body weight, hypoglycaemic episodes) and psycho-social adaptation (quality of life, self-efficacy, stress and perceived complexity). RESEARCH DESIGN AND METHODS: Fifteen adults with type 1 diabetes completed this 1-year, randomized, prospective, cross-over study. The three treatment strategies were categorized according to flexibility with insulin self-adjustments as follows: Simplified (SIMP) = meal plan based on food exchanges with no self-adjustments of insulin for food, exercise and stress; Qualitative (QUAL) = meal plan based on food exchanges with qualitative adjustment of insulin for food, exercise and stress; Quantitative (QUANT) = meal plan using carbohydrate counting with quantitative adjustment of insulin for food and qualitative adjustment for exercise and stress. All three strategies allowed for adjustments of insulin for preprandial blood glucose and the option of adjusting diet for exercise. All subjects followed each strategy for 3.5 months. Subjects kept detailed log sheets where they recorded preprandial blood glucose, insulin dosages, food intake, activity and stress level at least four times/day. The psycho-social aspects were determined with validated questionnaires that were completed before and after each strategy. RESULTS: There were no statistically significant differences in metabolic control, quality of life and self-efficacy between the three strategies. The mean (+/- s.e.) for HbA1 levels (normal < 8.5%) were: Baseline: 10.9+/-0.06 and End of SIMP = 9.7+/-0.03; QUAL = 9.5+/-0.04; QUANT = 10.2+/-0.04. Body weight and serum lipid levels did not change significantly. The frequency of severe hypoglycaemic episodes for the entire study was 20 episodes/100 patient-years. Perceived complexity of treatment strategy increased (p < 0.0001) from SIMP to QUANT (least to most flexible). Although the majority of subjects (n = 11) were following a strategy similar to SIMP prior to entering the study, 12 subjects chose to continue with QUAL, three with QUANT and none with SIMP at the end of the study. CONCLUSIONS: These results indicate that a strategy that allows for flexibility of self-adjustments of insulin and is not very complex (such as QUAL) may be the strategy of choice for intensive management programmes.
RCT Entities:
OBJECTIVE: To compare three intensive management strategies with respect to metabolic control (glycated haemoglobin, preprandial blood glucose, lipid profile, body weight, hypoglycaemic episodes) and psycho-social adaptation (quality of life, self-efficacy, stress and perceived complexity). RESEARCH DESIGN AND METHODS: Fifteen adults with type 1 diabetes completed this 1-year, randomized, prospective, cross-over study. The three treatment strategies were categorized according to flexibility with insulin self-adjustments as follows: Simplified (SIMP) = meal plan based on food exchanges with no self-adjustments of insulin for food, exercise and stress; Qualitative (QUAL) = meal plan based on food exchanges with qualitative adjustment of insulin for food, exercise and stress; Quantitative (QUANT) = meal plan using carbohydrate counting with quantitative adjustment of insulin for food and qualitative adjustment for exercise and stress. All three strategies allowed for adjustments of insulin for preprandial blood glucose and the option of adjusting diet for exercise. All subjects followed each strategy for 3.5 months. Subjects kept detailed log sheets where they recorded preprandial blood glucose, insulin dosages, food intake, activity and stress level at least four times/day. The psycho-social aspects were determined with validated questionnaires that were completed before and after each strategy. RESULTS: There were no statistically significant differences in metabolic control, quality of life and self-efficacy between the three strategies. The mean (+/- s.e.) for HbA1 levels (normal < 8.5%) were: Baseline: 10.9+/-0.06 and End of SIMP = 9.7+/-0.03; QUAL = 9.5+/-0.04; QUANT = 10.2+/-0.04. Body weight and serum lipid levels did not change significantly. The frequency of severe hypoglycaemic episodes for the entire study was 20 episodes/100 patient-years. Perceived complexity of treatment strategy increased (p < 0.0001) from SIMP to QUANT (least to most flexible). Although the majority of subjects (n = 11) were following a strategy similar to SIMP prior to entering the study, 12 subjects chose to continue with QUAL, three with QUANT and none with SIMP at the end of the study. CONCLUSIONS: These results indicate that a strategy that allows for flexibility of self-adjustments of insulin and is not very complex (such as QUAL) may be the strategy of choice for intensive management programmes.
Authors: Sofia Sterner Isaksson; Margareta Bensow Bacos; Björn Eliasson; Eva Thors Adolfsson; Araz Rawshani; Ulf Lindblad; Johan Jendle; Agneta Berglund; Marcus Lind; Mette Axelsen Journal: BMJ Open Diabetes Res Care Date: 2021-03
Authors: Richard M Bergenstal; Mary Johnson; Margaret A Powers; Alan Wynne; Aleksandra Vlajnic; Priscilla Hollander; Marc Rendell Journal: Diabetes Care Date: 2008-03-25 Impact factor: 19.112